Zyno Medical LLC
Complete recall history across all FDA and CPSC categories — 16 total recalls
Zyno Medical LLC appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.
Device Recalls (16)
FDA medical device enforcement actions by Zyno Medical LLC
| Date | Product | Reason | Class |
|---|---|---|---|
| May 7, 2025 | Z-800F Infusion System. Intended to provide intravenous infusion of parentera... | Unreleased software versions were installed on distributed devices without ve... | Class I |
| May 7, 2025 | Z-800W Infusion System. Intended to provide intravenous infusion of parentera... | Unreleased software versions were installed on distributed devices without ve... | Class I |
| May 7, 2025 | Z-800WF Infusion System. Intended to provide intravenous infusion of parenter... | Unreleased software versions were installed on distributed devices without ve... | Class I |
| May 7, 2025 | Z-800 Infusion System. Intended to provide intravenous infusion of parenteral... | Unreleased software versions were installed on distributed devices without ve... | Class I |
| Oct 18, 2024 | Z-800 Infusion System. Model/Catalog Number: Z-800, Z-800F, Z-800W, Z-800WF. ... | Potential for the battery to deplete over time from self-discharge and intern... | Class II |
| Sep 30, 2024 | Brand Name: Z-800 Infusion System Product Name: Z-800WF Model/Catalog Numbe... | For the Z-800WF pumps, the WiFi software was not compatible with the pump sof... | Class III |
| Sep 13, 2024 | Z-800 Infusion System, Model Numbers Z-800, Z-800F, Z-800W, Z-800WF; Softwar... | There is a defect in the air-in-line software algorithm. | Class I |
| Jun 4, 2024 | Zyno Medical Z800, Z800F, Z800W, and Z800WF Infusion Pumps | Zyno Medical has found that certain Z800, Z800F, Z800W, and Z800WF pumps have... | Class II |
| Dec 20, 2023 | Zyno Medical Z800 Large Volume Infusion Pumps -Intended to provide intravenou... | When utlizing the patient query feature on the Zyno Medical Z-800WF pumps wit... | Class II |
| May 29, 2019 | Zyno Medical Administration Set -105"ADMIN SET 20DP, W/2 Y SITE, CVCLMPS- For... | Administration sets assembled with inverted pinch clamp cause the fluid from ... | Class II |
| May 29, 2019 | Zyno Medical Administration Set -105"ADMIN SET 20DP W/FILTER 2YSITES CLMP- Fo... | Administration sets assembled with inverted pinch clamp cause the fluid from ... | Class II |
| Jul 29, 2016 | Zyno Medical Administration Set, Sterile. Rx For Use with Zyno Medical Infus... | Administration Set potential filter leaking | Class II |
| Jul 29, 2016 | Zyno Medical Administration Set, Sterile. RX For Use with Zyno Medical Infus... | Administration Set potential filter leaking | Class II |
| Jul 29, 2016 | Zyno Medical Administration Set Sterile. Rx For Use with Zyno Medical Infusi... | Administration Set potential filter leaking | Class II |
| Jul 29, 2016 | Zyno Medical Administration Set, Sterile. Rx For Use with Zyno Medical Infus... | Administration Set potential filter leaking | Class II |
| Jun 13, 2011 | Z-800 Volumetric Infusion System. For intravenous infusion of parenteral f... | Update Instruction For Use for Preventative Maintenance (PM) Schedule and add... | Class II |
Frequently Asked Questions
A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.
Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.
The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.
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